MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE

Catalog Number 03.812.308

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: august 9, 2011.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in denmark as follows: it was reported that three (3) transforaminal posterior atraumatic lumbar (t-pal) trial spacers (7mm, 8mm, and 9mm) broke during a surgical procedure on (b)(6) 2015.The procedure was completed with a twenty (20) minute delay.No reported harm to the patient, whose postoperative outcome was reported as "ok." this report is 1 of 3 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was completed: the ball at the coupling is broken off.The complaint article was analyzed by a microscopic investigation.Afterwards there was an evaluation of the fracture surface with a scanning electron microscopic with the help of an energy-dispersive x-ray spectroscopy performed.In addition there was also a hardening test performed.The macroscopic evaluation has shown clear evidence of mechanical damages.The investigation of the scanning electron microscope has shown that it is a distinct mixed fracture.This fracture is a clear evidence of a triaxle stress state which has led to this damage.The smudged areas of the fracture surface and the strong oxidation indicates that the break has progressed step by step.It is likely that during the application an initial crack has formed which has led to the failure of the instrument.The hardening test has shown a deviation to the specification.A product development evaluation was completed: three parts received.Parts show normal wear and tear.Proximal tips are broken off and have also been received at investigation site.It could not be determined what lead to the failure of material.It is likely that hammering in both directions (push and pull) lead to the failure.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Manufacturing investigation evaluation: received one (1) article of t-pal small trial implant (part 03.812.308) for manufacturing investigation.The knob on the end of the part is broken off.During the manufacturing investigation, the hardness has been measured on the outer diameter ø4.45 mm.The location of the hardness measuring point is defined on the relevant product drawings.The result was within specification and the value documented below.Therefore, a manufacturing related issue can be excluded.It is likely that the breakage of the applicator inner shaft was caused by the application of high mechanical forces during use.No manufacturing related issue was identified and/or confirmed.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5297762
• MDR Text Key: 33507436
• Report Number: 3003875359-2015-10543
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.308
• Device Lot Number: 7526729
• Other Device ID Number: (01)07611819418981(10)7526729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2016; 02/22/2016; 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 03.812.004 - T-PAL SPACER APPLICATOR KNOB
• Patient Age: 62 YR